Using Mobile Technology to Reduce Stereotypy

Child Development Disorders, Pervasive Clinical Trial

Official title:

Using Mobile Technology to Reduce Stereotypy in Children With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124720
• Other study ID #: CERFAS-2014-15-030-P
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: February 2019

Study information

• Verified date: September 2019
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nearly all children with autism spectrum disorders engage in non-functional repetitive vocal and motor behaviours commonly referred to as stereotypy. These repetitive behaviours may considerably interfere with the child's daily functioning, learning, and social inclusion. As such, stereotypy generally has a negative impact on the child and family's health and quality of life. Several behavioural interventions have been developed to reduce engagement in stereotypy in children with autism spectrum disorders, but the limited number of specialists available, the long waiting lists associated with public health services in Canada, and the high costs of private services have considerably restricted accessibility. One potential solution to the limited availability and high costs of services is using a mobile application to recommend, teach, and monitor interventions designed to reduce engagement in stereotypy. To this end, the purpose of the study is to evaluate the effects of the iSTIM (i.e., individualized Stereotypy Treatment Integrated Modules), a mobile application designed to assist parents in reducing stereotypy in children with autism spectrum disorders. Specifically, we will assess whether the iSTIM correctly estimates the frequency or duration of stereotypy, offers suggestions consistent with recommended clinical practices, effectively reduces engagement in stereotypy, and is socially acceptable, safe, and easy to use for parents of children with autism spectrum disorders. The results of the study will allow us to determine whether the mobile application may be used to treat this core symptom in children with autism spectrum disorders, which could potentially reduce waiting times and costs of providing health services to this population. By reducing engagement in stereotypy, the iSTIM may also promote and facilitate the social participation as well as improve the quality of life and health of children with autism spectrum disorders and their families.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of autism spectrum disorders

• Must engage in at least one form of stereotypy

Exclusion Criteria:

• Stereotypy occurs less than 12 times per hour (or less than 20% of time)

• The form of stereotypy is potentially dangerous for the person (e.g., head banging, self-biting)

• The form of stereotypy is maintained by social consequences (e.g., attention, task avoidance)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities

Intervention

Behavioral:
• iSTIM
Trained research assistants and parents will implement the assessments and interventions recommended by the iSTIM mobile application during sessions lasting between 10 and 60 minutes

Locations

Country	Name	City	State
Canada	Monarch House	Mississauga	Ontario
Canada	CRDITED de Montréal	Montreal	Quebec
Canada	Gold Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and duration of stereotypy	Direct observation of the frequency and duration of stereotypy during 10- to 60-minute sessions	2 to 4 times per week over 8 to 16 weeks
Secondary	Social validity score	The user responds to a social validity questionnaire	Immediately following the end of the intervention (i.e., after 8 to 16 weeks)